SAN DIEGO, CA and LEIDEN, THE NETHERLANDS--(Marketwired - June 18, 2013) - Santarus, Inc.
(NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced
that the U.S.
Food and Drug Administration (FDA) has accepted for filing the Biologics
License
Application (BLA) for the investigational drug RUCONEST® (recombinant
human C1
esterase inhibitor) 50 IU/kg. Santarus and Pharming are seeking U.S.
marketing
approval of RUCONEST for the treatment of acute angioedema attacks in
patients
with hereditary angioedema (HAE). The FDA indicated that as part of its
review
it plans to present the BLA to the Blood Products Advisory Committee.
Pursuant
to the Prescription Drug User Fee Act (PDUFA) guidelines, Santarus and
Pharming
expect the FDA will complete its review or otherwise respond to the
RUCONEST BLA
by April 16, 2014.

The safety and efficacy of RUCONEST for the treatment of HAE attacks were
evaluated in a clinical program that included a Phase III randomized
placebo-controlled study conducted under a Special Protocol Assessment
agreement with
the FDA. The RUCONEST clinical program also included two additional
randomized
placebo-controlled studies and several open label treatment studies.

"RUCONEST is the first recombinant C1 esterase inhibitor developed with the
goal
of treating the pain and swelling associated with acute HAE attacks," said
Gerald T. Proehl, president and chief executive officer of Santarus. "We
believe RUCONEST has the potential to be an important new therapeutic
option for
patients experiencing acute HAE attacks based on the data contained in the
BLA
from ten clinical studies covering 940 administrations of the drug."

"Acceptance of the BLA is a pivotal event for Pharming and represents the
most
significant step to date in our efforts to obtain marketing approval for
RUCONEST in the U.S.," said Sijmen de Vries, chief executive officer of
Pharming. "We look forward to working with our colleagues at Santarus to
move
RUCONEST through the U.S. regulatory process, and ultimately provide a new
HAE
therapy to physicians and the patients they treat."

Santarus licensed certain exclusive rights from Pharming to commercialize
RUCONEST in North America for the treatment of acute attacks of HAE as well
as
other potential future indications. Under the terms of the license
agreement, a
$5 million milestone is payable to Pharming as a result of the FDA
acceptance
for review of the BLA for RUCONEST.

About RUCONEST and Hereditary Angioedema

RUCONEST (INN conestat alfa) is a recombinant version of the human protein
C1
esterase inhibitor, and is produced with Pharming's proprietary transgenic
technology. RUCONEST is approved in Europe for the treatment of acute
angioedema
attacks in patients with HAE, a genetic disorder in which the patient is
deficient in or lacks a functional plasma protein C1 esterase inhibitor,
resulting in unpredictable and debilitating episodes of intense swelling.
The
swelling may occur in one or more anatomical areas, including the
extremities,
face, trunk, genitals, abdomen and upper airway. The frequency and severity
of
HAE attacks vary and are most serious when they involve laryngeal edema,
which
can close the upper airway and cause death by asphyxiation. According to
the
U.S. Hereditary Angioedema Association, epidemiological estimates for HAE
range
from one in 10,000 to one in 50,000 individuals. RUCONEST is an
investigational
drug in the U.S. and has been granted orphan drug designation by the FDA
both
for the treatment of acute attacks of HAE and for prophylactic treatment of
HAE.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of
unmet
medical needs. RUCONEST® is a recombinant human C1 esterase inhibitor
approved
for the treatment of angioedema attacks in patients with HAE in all 27 EU
countries plus Norway, Iceland and Liechtenstein, and is distributed in the
EU
by Swedish Orphan Biovitrum. RUCONEST® is partnered with Santarus,
Inc. (NASDAQ: SNTS) in North America and a Biologics License Application for RUCONEST is
under
review by the U.S. Food and Drug Administration. The product is also being
evaluated for various follow-on indications. Pharming has a unique GMP
compliant, validated platform for the production of recombinant human
proteins
that has proven capable of producing industrial volumes of high quality
recombinant human protein in a more economical way compared to current cell
based technologies. Pharming now plans to utilise this platform for the
development of rhFVIII for the treatment of Haemophilia A. Additional
information is available on the Pharming website, www.pharming.com.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on
acquiring,
developing and commercializing proprietary products that address the needs
of
patients treated by physician specialists. The company's current commercial
efforts are focused on five products. UCERIS® (budesonide) extended
release
tablets for the induction of remission in patients with active, mild to
moderate
ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for
the
treatment of certain upper gastrointestinal disorders are promoted to
gastroenterologists. GLUMETZA® (metformin hydrochloride extended
release
tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are
indicated as
adjuncts to diet and exercise to improve glycemic control in adults with
type 2
diabetes, and FENOGLIDE® (fenofibrate) tablets, which is indicated as
an adjunct
to diet to reduce high cholesterol, are promoted to endocrinologists and
other
physicians who treat patients with type 2 diabetes. Full prescribing and
safety
information for Santarus' products is available at www.santarus.com or by
contacting Santarus at 1-888-778-0887.

Santarus' product development pipeline includes the investigational drug
RUCONEST® (recombinant human C1 esterase inhibitor). A Biologics
License
Application for RUCONEST for the treatment of acute angioedema attacks in
patients with hereditary angioedema is under review by the U.S Food and
Drug
Administration with a response expected in April 2014. Santarus is also
developing rifamycin SV MMX®, which is in Phase III clinical testing
for the
treatment of travelers' diarrhea. In addition, the company has completed a
Phase I clinical program with SAN-300, an investigational monoclonal
antibody.
More information about Santarus is available at www.santarus.com.

Santarus and Pharming caution you that statements included in this press
release
that are not a description of historical facts are forward-looking
statements.
The inclusion of forward-looking statements should not be regarded as a
representation by Santarus or Pharming that any of its plans or objectives
will
be achieved. Actual results may differ materially from those set forth in
this
release due to the risks and uncertainties inherent in Santarus and
Pharming's
businesses, including, without limitation: whether the FDA will approve
the
RUCONEST BLA in a timely manner or at all; whether the FDA will concur with
the
clinical interpretation of the Phase III study results or the conduct of
the
study; whether the FDA ultimately will require additional clinical studies
or
other development programs before approving RUCONEST; risks related to
Santarus'
dependence on Pharming for many functions related to RUCONEST, and
Pharming's
ability to continue to perform these functions based on its limited
financial
resources; risks related to the license and supply arrangements between
Santarus
and Pharming, including the potential for termination of the arrangements;
other
difficulties or delays in development, testing, manufacturing and marketing
of,
and obtaining and maintaining regulatory approvals for, Santarus and
Pharming's
products; and other risks detailed in prior press releases as well as in
public
periodic filings with the Securities and Exchange Commission, including
Santarus' Quarterly Report on Form 10-Q for the quarter ended March 31,
2013.

You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement and
neither Santarus nor Pharming undertakes any obligation to revise or update
this
news release to reflect events or circumstances after the date hereof,
except as
may be required by law. This caution is made under the safe harbor
provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus®, FENOGLIDE®, UCERIS®, and ZEGERID® are
registered trademarks of
Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories
International
S.r.l. licensed exclusively in the United States to Depomed, Inc.
CYCLOSET® is a
trademark of VeroScience LLC. MMX® is a trademark of Cosmo
Technologies Limited.
RUCONEST® is a trademark of Pharming Group N.V.